Label: CHEST RUB VAPORIZING- menthol and camphor and eucalyptus oil gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 4, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor            4.7%

    Menthol             1.0%

    Eucalyptus Oil   1.0%

  • PURPOSE

    Purpose

    Decongestant

  • INDICATIONS & USAGE

    Uses

    • on chest and throat, helps temporarily relieve cough due to common cold
    • on joints and muscles, temporary relieves minor aches and pain
  • WARNINGS

    Warnings

    For external use only, avoid contact with eyes.

  • DO NOT USE

    Do not use

    • by mouth
    • in nostrils
    • with tight bandages
    • on wounds or damaged skin
  • ASK DOCTOR

    Ask doctor before use if you have,

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma, emphysema or smoking
  • WHEN USING

    When using this product, do not

    • heat
    • microwave
    • add to hot water or any container where heating water. May cause splattering and result in burns
  • STOP USE

    Stop use and ask a doctor if:

    • cough lasts more than 7 days, comes back, or fever, rash or persistent headache. These could be sign of a serious conditions
    • muscle aches and pain persist more than 7 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    If ingested get medical help or contact a Poison control center immediately

  • DOSAGE & ADMINISTRATION

    Directions:

    adults and children 2 years and over:

    • rub a thick layer on chest and throat or rub on sore aching muscles
    • keep clothing loose around chest/throat to help vapors reach the nose/mouth
    • repeat up to 3 times per 24 hours or as directed by doctor

    do not use on children under 2 years unless directed by doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients

    cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, and turpentine oil

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    CHEST RUB VAPORIZING GEL

    NASAL DECONGESTANT

    COUGH SUPPRESSANT

    NET WT. 4 OZ (113g)

    label

  • INGREDIENTS AND APPEARANCE
    CHEST RUB VAPORIZING 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70201-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70201-004-09113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/03/2015
    Labeler - North & South Wholesalers LLC (004948495)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(70201-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!